Strict regulations block commercial launch of bloodless syringe in Korea
이 글자크기로 변경됩니다.
(예시) 가장 빠른 뉴스가 있고 다양한 정보, 쌍방향 소통이 숨쉬는 다음뉴스를 만나보세요. 다음뉴스는 국내외 주요이슈와 실시간 속보, 문화생활 및 다양한 분야의 뉴스를 입체적으로 전달하고 있습니다.
Scientists criticize the country¡¯s current regulations on the innovative medical device designation for fast-track marketing review are too strict to encourage innovations.
Innotherapy, a Korean bio-inspired technology company, developed a needle coated with a hemostatic substance and filed for its designation as an innovative medical device to the Ministry of Food and Drug Safety last June. The application was referred to the Ministry of Health and Welfare, but the top health regulator said the bloodless needle does not meet the innovative medical device criteria, adding it is difficult to decide in terms of safety although its innovativeness is recognized.
In response, Innotherapy said it is working on supplemental documents to beef up safety data and re-submit its application this year.
The needle was first developed by KAIST scientist Lee Hae-shin and in recognition of his invention Lee received the scientist award of the month from the government in October 2018. The needle is coated with a hemostatic substance and an adhesive substance similar to what mussels use to cling to rocks against crashing waves.
A patch-type product using the same substance was already approved for its commercial use with approval from the Ministry of Food and Drug Safety in 2015 and from the U.S. Food and Drug Administration in 2016.
A bloodless syringe can protect healthcare professionals from secondary infections that are mediated by the patient's blood, such as AIDS, Ebola, and hepatitis. This syringe can also be used for injection treatment for patients with weak hemostasis due to hemophilia or diabetes.
It is difficult to understand that a patch product with the same substance has already been commercialized, but the application for this needle product is not accepted for safety reasons, Lee said.
[¨Ï Maeil Business Newspaper & mk.co.kr, All rights reserved]
Copyright © 매일경제 & mk.co.kr. 무단 전재, 재배포 및 AI학습 이용 금지
- SeAH Besteel to split into holding entity and unlisted special steel business unit - Pulse by Maeil Business News Korea
- SK Bioscience, SK IET employees enjoy profits from IPO, but Krafton with loss - Pulse by Maeil Business News Korea
- SK Networks to invest $8.38 mn in Level 2 EV CPO Everon - Pulse by Maeil Business News Korea
- Law & Company completes Series C investment, pooling 23 billion won - Pulse by Maeil Business News Korea
- Seoul city gov’t vows to up EV charging stations in capital by 10-fold in 5 years - Pulse by Maeil Business News Korea
- 강경준, 상간남 피소…사랑꾼 이미지 타격 [MK픽] - 스타투데이
- “BIMO는 문제없어” 자신한 HLB, 시장 반응은 ‘글쎄’ [재계 TALK TALK]
- “급작스런 비극”…가수 故 박보람, “급성알코올중독으로 사망 확인” - MK스포츠
- 이찬원, 이태원 참사에 "노래 못해요" 했다가 봉변 당했다 - 스타투데이
- 양희은·양희경 자매, 오늘(4일) 모친상 - 스타투데이